Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds

September 2, 2026 updated by: Lohmann & Rauscher
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This clinical investigation will be conducted as multicenter, randomized in parallel groups, non-inferiority controlled trial. After randomization patients will receive wound debrided with the investigational device or the comparator device during one study visit. During the study visit patients will have clinical examination and wound photos will be taken.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Lodz, Poland, 94-102
        • MelissaMed Poradnia
      • Lodz, Poland, 94-238
        • MIKOMED Sp. z.o.o.
      • Lublin, Poland, 20-640
        • NZOZ Neuromed M. i M. Nastaj
      • Ostróda, Poland, 14-100
        • Specjalistyczny Osrodek Leczniczo Badawczy
      • Wroclaw, Poland, 54-616
        • Lecran - Centrum Opieki Nad Ranami-Kunickiego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patient is legally capable
  • Patient has signed written informed consent

  • Presence of one of the following wounds

    • Venous lower leg ulcer
    • Arterial ulcer
    • Diabetic ulcer
    • Pressure ulcer
    • Post-operative wound healing by secondary intention
    • Traumatic wound
    • Surgical wound
    • Burn or scald (grade III: after surgical debridement)
    • Epidermolysis Bullosa
  • Wound area >4cm2
  • The entire wound area can be displayed on one photo from a distance of 25-30 cm
  • Covered with at least 30% debris, necrosis, slough, fibrotic tissue

Exclusion Criteria:

  • Known allergy and/or hypersensitivity to Debrisoft® Duo or any of the product components
  • Pregnancy or breast feeding
  • Patient is illiterate
  • Participation in a interventional clinical trial within the last 14 days and during participation in this study
  • Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and/ or interpretation of the study results
  • severe pain or hyperesthesia in the wound area
  • history of drug or alcohol abuse
  • chronic analgesic use (especially opioids) that could influence baseline pain perception
  • cognitive impairment, which may affect the ability to accurately self-report pain
  • Use of anaesthesia before the debridment procedure
  • presence of hard necrotic tissue or other tissue which should not be debrided in general. Other types of hard necrotic tissue requiring debridement, as determined by the investigator, are permitted and may be also pre-moistened before the procedure if deemed necessary

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Debrisoft Duo
Patients will be treated with the investigational device which is a two sided pad for the debridement of a wide range of wounds. The soft, wide side of the device is identical to the comparator device. The textured, beige side is unique to the investigational device and makes it easy to loosen strongly adherent, fibrinous wound debris.
Device: two sided debridement pad
two sided debridement pad
Active Comparator: Debrisoft Pad
Patients will be treated with the comparator device which is a one sided pad for the debridement of a wide range of wounds. The device has the same soft, wide side as the investigational product but does not have the aditional textured, beige side.
Device: one sided debridment pad
one sided debridment pad

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relative reduction of fibrinous and necrotic tissue/slough/debris measured by W.H.A.T.
Time Frame: 1 day
Wound photos will be taken. On these photos, the amount of fibrinous and necrotic tissue/slough/debris in the wound bed before and after debridement will be measured by W.H.A.T. (Wound Healing Analyzing Tool).
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relative reduction of fibrinous and necrotic tissue/slough/debris measured by he investigator
Time Frame: 1 day
The amount of fibrinous and necrotic tissue/slough/debris in the wound bed before and after debridement will be measured by the investigator.
1 day
Rate of device-related adverse events (device safety)
Time Frame: 1 day
Frequency and character of device deficiencies (DDs), adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs) and incidents.
1 day
Change of wound bed condition, defined by the combination of the following parameters:
Time Frame: 1 day
  • Change in grade of exudate (from very high to none)
  • Change in type of exudate (from haemorrhagic to serous)
  • Change of the wound surrounding skin (presence or abscence of normal, erosive, dry/scaling, dry cracking, oeadematous, red or discoloured skin and cream residues)
  • Change of the wound bed and wound edges (presence or abscence of debris, discoloration, maceration, hyperkeratosis, smooth skin, thickened/rolled edges, undermining, vital tissue, biofilm)
  • Removal of biofilm (estimated by the user)
1 day
Wound related pain
Time Frame: 1 day
Wound related pain will be measured directly before, during and 10 +/-2 minutes using NRS-11 scale
1 day
Time needed for debridement
Time Frame: 1 day
Time needed for the debridement procedure will be assessed using a stopper
1 day
Amount of products
Time Frame: 1 day
Amount of products that were used during one debridement session will be assessed.
1 day
Patient satisfaction
Time Frame: 1 day
Patient satisfaction with the treatment procedure on a scale from 1-5
1 day
User satisfaction
Time Frame: 1 day
User satisfaction assessed via a questionnaire
1 day

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in wound size
Time Frame: 1 day
Wound size will be compared before and after the debridement procedure
1 day
Results of biopsy or smear
Time Frame: 1 day
If performed during clinical routine, results of biopsy or smear will be assessed
1 day
Removal of biofilm
Time Frame: 1 day
Change in the presence of biofilm before and after debridement will be investigated using MolecuLightDX. This will only be done at one of the five participating sites.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lohmann & Rauscher

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AXCELLANT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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